A Study of Korean Society of Spine Surgery on the Outcomes of Anterior Cervical Discectomy and Fusion

The purpose of this study is firstly to determine the efficacy of cervical plate for anterior cervical discectomy and fusion using cervical cage, and secondly to investigate the determining factors for surgical outcomes.

Study Overview

• Status: Active, not recruiting
• Conditions: Myelopathy; Radiculopathy, Cervical
• Intervention / Treatment: Procedure: anterior cervical discectomy and fusion; Device: Cage and Plate; Device: Cage alone

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 602-702
    • Inje University Busan Paik Hospital
  • Busan, Korea, Republic of, 602-702
    • Inje university Haeundae Paik Hospital
  • Busan, Korea, Republic of, 602-702
    • Pusan National University Hospital
  • Daegu, Korea, Republic of, 602-702
    • Kyungpook National University Hospital
  • Daejeon, Korea, Republic of, 602-702
    • Eulji University Hospital
  • Daejeon, Korea, Republic of, 602-702
    • The Catholic University of Korea Daejeon St. Mary's Hospital
  • Gwangju, Korea, Republic of, 602-702
    • Chonnam National University Hospital
  • Gwangju, Korea, Republic of, 602-702
    • Chosun university hospital
  • Gwangju, Korea, Republic of, 602-702
    • Kwangju Christian hospital
  • Incheon, Korea, Republic of, 602-702
    • Inha University Hospital
  • Incheon, Korea, Republic of, 602-702
    • The Catholic University of Korea, Incheon St. Mary's Hospital
  • Seoul, Korea, Republic of, 602-702
    • Asan Medical Center, University of Ulsan College of Medicine
  • Seoul, Korea, Republic of, 602-702
    • Chung-Ang University Hospital
  • Seoul, Korea, Republic of, 602-702
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of, 602-702
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 602-702
    • National Police Hospital
  • Seoul, Korea, Republic of, 602-702
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 602-702
    • SMG-SNU Boramae Medical Center
  • Seoul, Korea, Republic of, 602-702
    • Soonchunhyang University Seoul Hospital
  • Seoul, Korea, Republic of, 602-702
    • VHS Medical Center
  • Gyounggi
    • Ilsan, Gyounggi, Korea, Republic of, 602-702
      • Dongguk University Ilsan Hospital
  • Gyounggi-do
    • Ilsan, Gyounggi-do, Korea, Republic of, 602-702
      • National Health Insurance Service Ilsan Hospital
  • Gyounggido
    • Dongan, Gyounggido, Korea, Republic of, 602-702
      • Hallym University Dongtan Sacred Heart Hospital
    • Dongan, Gyounggido, Korea, Republic of, 602-702
      • HALLYM UNIVERSITY HOSPITAL
    • Ilsan, Gyounggido, Korea, Republic of, 602-702
      • Inje University Ilsan Paik Hospital
    • Seongnam, Gyounggido, Korea, Republic of, 602-702
      • Bundang Jesaeng Hospital
  • Gyoungido
    • Seongnam, Gyoungido, Korea, Republic of, 602-702
      • CHA Bundang Medical Center, CHA University
  • Gyoungnam
    • Yangsan, Gyoungnam, Korea, Republic of, 602-702
      • Pusan National University Yangsan Hospital
  • Jeonbuk
    • Iksan, Jeonbuk, Korea, Republic of, 602-702
      • Wonkwang University School of Medicine & Hospital
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 110-744
      • Seoul National University Hospital
  • Kyoungpook
    • Pohang, Kyoungpook, Korea, Republic of, 602-702
      • Pohang Semyung Christianity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• degenerative cervical disease
• radiculopathy or myelopathy refractory to conservative treatment
• be scheduled to undergo one segment anterior cervical discectomy and fusion
• age is more than 19 years old
• all requirements of preoperative image studies are satisfied

Exclusion Criteria:

• previous neck surgery or radiation treatments at neck area
• fusion at adjacent segments
• two segment fusion is expected
• C2-3 or C7-T1
• high risk for additional cervical surgery within one year
• ossification of posterior longitudinal ligaments, trauma, infection, tumor, congenital or developmental disease
• inadequate radiological images
• patient is not expected to be observed at long term follow-up (foreigner, international student)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cage and Plate; anterior cervical discectomy and fusion surgery at one segment is performed using cervical cage and plate system	Procedure: anterior cervical discectomy and fusion; anterior cervical discectomy and fusion with anterior plating or not; Device: Cage and Plate; anterior cervical discectomy and fusion is performed using cervical cage and plate
Experimental: Cage alone; anterior cervical discectomy and fusion surgery at one segment is performed using only cervical cage without plate	Procedure: anterior cervical discectomy and fusion; anterior cervical discectomy and fusion with anterior plating or not; Device: Cage alone; anterior cervical discectomy and fusion is performed using cage alone with plate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical fusion status	Cervical fusion rates (%) is compared using CT and flexion/extension X-ray between two groups. For statistical analysis, Chi-Square test is used.	five year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
predisposing factor of non-union	Using logistic regression analysis, odds ratio of each variable is calculated for non-union after anterior cervical discectomy and fusion.	one year after surgery
risk factors of dysphagia	a specific questionnaire is used for assessment for dysphagia after anterior cervical discectomy and fusion. For comparison of dysphagia rates(%) between two group, Chi-square analysis is used. Furthermore, odds ratio of each variable for dysphagia is calculated for logistic regression analysis.	one year after surgery
risk factors of dysphonia	a specific questionnaire is used for assessment for dysphonia after anterior cervical discectomy and fusion. For comparison of dysphonia rates(%) between two group, Chi-square analysis is used. Furthermore, odds ratio of each variable for dysphonia is calculated for logistic regression analysis.	one year after surgery
factors for quality of life	Firstly, total cost is calculated for each case. European Quality of Life-5 Dimensions is also used for assessment of quality of life after operation. Between two groups, quality of life per cost is evaluated.	one years after operation
risk factors for adjacent segment degeneration	The rates (%) of radiological and clinical adjacent segment degeneration is evaluated using X-ray and clinical evaluation in both groups. For statistical analysis, Chi-Square test is used for comparison of rates (%) for adjacent segment degeneration. Furthermore, logistic regression test is also used for calculating odds ratio for adjacent segment degeneration	five year after surgery
correlation between osteoporosis and fusion	The rates (%) of fusion is evaluated in relation to osteoporosis. For statistical analysis, Chi-Square test is used for comparison between osteoporosis group and non-osteoporosis group.	one year after surgery
relation between brace wearing and fusion	The rates (%) of fusion is evaluated using X-ray and CT scan according to kinds of brace in both groups. For statistical analysis, Chi-Square test is used for comparison of fusion rates (%).	one year after surgery
surgical outcomes for combined uncinectomy	In relation with uncinectomy, the clinical outcomes (VAS, NDI) and radiological outcome (fusion rates(%)) is compared using t-test and Chi-square test.	one year after surgery
change of neck motion after surgery	Serial changes of whole cervical neck motion (degree) is evaluated and compared between pre- and post-operative states. statistical significance is evaluated using one-way ANOVA or paired t test.	one year after surgery
neuropathy after anterior cervical discectomy and fusion surgery	The occurrence rates(%) of neuropathic pain is evaluated using a specific questionnaires. Several factors to be associated with neuropathic pain is evaluated using logistic regression analysis.	one year after surgery
relation between the method of bone graft and fusion	The rates (%) of fusion is evaluated using X-ray and CT scan according to methods of bone graft in both groups. For statistical analysis, Chi-Square test is used for comparison of fusion rates(%) in relation to the bone graft method.	one year after surgery
analysis of complication rates after anterior cervical discectomy and fusion surgery	After anterior cervical discectomy and fusion, complication rates (%) was evaluated, and this is compared between two groups. Further, factors to be associated with complication rates is assessed using Chi-square test	one year after surgery
The correlation between existence of co-morbidity and surgical outcome	The clinical and radiological outcomes is evaluated using VAS, NDI, and X-ray in relation with existence of coexistence. T-test and Chi-square test are used for statistical analysis for comparison between co-morbidity group and non-co-morbidity group.	one year after surgery
The correlation analysis between smoking history and surgical outcome (fusion rates, improvement of pain and disability)	The surgical outcomes such as fusion rates(%), VAS, and NDI score were evaluated in relation with smoking history. For analysis, Chi-square and t-test are used for comparison between smoking group and non-smoking group.	one year after surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Korean Society of Spine Surgery
• Investigators: Principal Investigator: Jin S. Yeom, MD, PhD, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): September 1, 2017
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 21, 2013
• First Submitted That Met QC Criteria: July 25, 2013
• First Posted (Estimated): July 30, 2013

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: degenerative cervical disease; anterior cervical discectomy and fusion; plate and cage; cage alone
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy; Spinal Cord Diseases
• Other Study ID Numbers: KSSS-001